Joint PainNCT04764110
Short-term Impact of Cyplexinol® on Self-reported Joint Pain
A study testing Cyplexinol in people with Joint Pain, run by University of Memphis at 1 site in United States.
Trial summary
In this study, the impact of 900 mg Cyplexinol® taken daily on joint pain over a period of 15 days in comparison with a placebo will be determined using a cross-over double blind design with a 13 day wash out period. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Joint Pain
- What is being tested?
- Cyplexinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2021to 28 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body mass index (BMI) between 18-29.9 kg/m2 (not obese)
- no consumption of alcohol-containing beverages within 48 hours of testing
- experiencing self-reported joint pain with a minimum pain rating of 3/10 for at least the past 30 days
- engaged in structured exercise 2 or more days per week for the past 6 months or longer
- a negative verbal pre-study drug screen (alcohol abuse, amphetamines, benzodiazepines, cocaine, opioids, phencyclidine, barbiturates, cotinine), no history of use of illicit drugs or other substances of abuse within 12 months of the screening visit
Who cannot join
- pregnant
- tobacco user
- active infection or illness of any kind
- rheumatic or osteoarthritic diagnosis
- Using anti-inflammatory medicines, pain medications, or dietary supplements (or not willing to cease for one-month prior to participation and throughout study)
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Nutraceutical and Dietary Supplement Reseach
Memphis, Tennessee, 38152
About this study
Official title: Short-term Impact of Cyplexinol® on Inflammatory Status and Related Measures in Men and Women With Self-reported Joint Pain
In this study, the impact of 900 mg Cyplexinol® taken daily on joint pain over a period of 15 days in comparison with a placebo will be determined using a cross-over double blind design with a 13 day wash out period. In addition, we will measure cytokine production and related variables during the two hour after subjects ingest a single dosage of Cyplexinol® or placebo on days 1 and 15.
Read the detailed description
Chronic inflammation can induce joint pain, which is a common problem among adult men and women. ZyCal Bioceuticals is a manufacturer of natural ingredients and finished nutritional supplements to support bone and joint health in humans. The core ingredient in all ZyCal products is Cyplexinol® (a Bone Morphogenetic Protein [BMP] Complex). BMP complexes have been shown to activate mesenchymal stem cells to help the body regenerate osteoblasts and chondrocytes. BMPs were initially identified in the 1970's as osteogenic factors which stimulate activation, proliferation, and differentiation of osteoprogenitor cells by binding BMP receptors and subsequent signaling through the SMAD pathway. BMPs have also been shown to reduce inflammation and promote healthy inflammatory signaling in joints and other tissues.
Cyplexinol® is delivered in the dietary supplement called Ostinol™, which has been safely used in oral form by thousands of people since 2007 for bone and joint health. Currently Cyplexinol® is considered a dietary supplement ingredient and has been awarded GRAS (generally recognized as safe).
Studies have been conducted to evaluate the safety and efficacy of Cyplexinol® as a dietary supplement for joint health (Garian, 2012; Scaffidi, 2017). Dosages of 150mg Cyplexinol® have been compared to a placebo (negative control) alone or in combination with glucosamine /chondroitin in randomized controlled trials for 4 -12 weeks. Endpoints examined have included joint stiffness, inflammation, pain, and overall quality of life. However, to date, no short-term studies have been conducted using Cyplexinol®, nor have any acute studies evaluated the impact of this agent on immune function.
In this study, the impact of 900 mg Cyplexinol® taken daily on joint pain over a period of 15 days in comparison with a placebo will be determined using a cross-over double blind design with a 13 day wash out period. In addition, we will measure cytokine production and related variables during the two hour post ingestion period after subjects ingest a single dosage of Cyplexinol® or placebo on days 1 and 15.
- Conditions
- Joint Pain
- Being tested
- Cyplexinol, Placebo
- Keywords
- Cyplexinol, Inflammation
- Medical subject headings
- Arthralgia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyplexinolDietary supplement
partially hydrolyzed Collagen and its associated proteins including Bone Morphogenetic Proteins (BMPs)
PlaceboOther
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Cyplexinol | Experimental | 900 mg daily (2 capsules) for 15 days Receives: Dietary Supplement: Cyplexinol |
| Placebo | Placebo comparator | 2 capsules daily for 15 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNF-alpha
TNF-alpha measured in blood
Measured: baseline of day 1
TNF-alpha
TNF-alpha measured in blood
Measured: baseline of day 15
TNF-alpha
TNF-alpha measured in blood
Measured: 60 min after treatment ingestion of day 1
TNF-alpha
TNF-alpha measured in blood
Measured: 60 min after treatment ingestion of day 15
TNF-alpha
TNF-alpha measured in blood
Measured: 120 min after treatment ingestion of day 1
TNF-alpha
TNF-alpha measured in blood
Measured: 120 min after treatment ingestion of day 15
IL-6
IL-6 measured in blood
Measured: baseline of day 1
IL-6
IL-6 measured in blood
Measured: baseline of day 15
IL-6
IL-6 measured in blood
Measured: 60 min after treatment ingestion of day 1
IL-6
IL-6 measured in blood
Measured: 60 min after treatment ingestion of day 15
IL-6
IL-6 measured in blood
Measured: 120 min after treatment ingestion of day 1
IL-6
IL-6 measured in blood
Measured: 120 min after treatment ingestion of day 15
IL-10
IL-10 measured in blood
Measured: baseline of day 1
IL-10
IL-10 measured in blood
Measured: baseline of day 15
IL-10
IL-10 measured in blood
Measured: 60 min after treatment ingestion of day 1
IL-10
IL-10 measured in blood
Measured: 60 min after treatment ingestion of day 15
IL-10
IL-10 measured in blood
Measured: 120 min after treatment ingestion of day 1
IL-10
IL-10 measured in blood
Measured: 120 min after treatment ingestion of day 15
IL-1beta
IL-1beta measured in blood
Measured: baseline of day 1
IL-1beta
IL-1beta measured in blood
Measured: baseline of day 15
IL-1beta
IL-1beta measured in blood
Measured: 60 min after treatment ingestion of day 1
IL-1beta
IL-1beta measured in blood
Measured: 60 min after treatment ingestion of day 15
IL-1beta
IL-1beta measured in blood
Measured: 120 min after treatment ingestion of day 1
IL-1beta
IL-1beta measured in blood
Measured: 120 min after treatment ingestion of day 15
osteocalcin
osteocalcin measured in blood
Measured: baseline day 1
osteocalcin
osteocalcin measured in blood
Measured: baseline day 15
osteocalcin
osteocalcin measured in blood
Measured: 60 min after treatment ingestion of day 1
osteocalcin
osteocalcin measured in blood
Measured: 60 min after treatment ingestion of day 15
osteocalcin
osteocalcin measured in blood
Measured: 120 min after treatment ingestion of day 1
osteocalcin
osteocalcin measured in blood
Measured: 120 min after treatment ingestion of day 15
alkaline phosphatase
alkaline phosphatase measured in blood
Measured: baseline day 1
alkaline phosphatase
alkaline phosphatase measured in blood
Measured: baseline day 15
alkaline phosphatase
alkaline phosphatase measured in blood
Measured: 60 min after treatment ingestion of day 1
alkaline phosphatase
alkaline phosphatase measured in blood
Measured: 60 min after treatment ingestion of day 15
alkaline phosphatase
alkaline phosphatase measured in blood
Measured: 120 min after treatment ingestion of day 1
alkaline phosphatase
alkaline phosphatase measured in blood
Measured: 120 min after treatment ingestion of day 15
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
Measured: baseline day 1
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
Measured: baseline day 15
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
Measured: 60 min after treatment ingestion of day 1
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
Measured: 60 min after treatment ingestion of day 15
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
Measured: 120 min after treatment ingestion of day 1
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
Measured: 120 min after treatment ingestion of day 15
Joint pain visual analog scale
A 100mm visual analog scale will be used to assess joint pain. Scores range from 0 (subject strongly disagreeing with prompt) to 100 (strongly agree).
Measured: Day 1 of treatment
Joint pain visual analog scale
A 100mm visual analog scale will be used to assess joint pain. Scores range from 0 (subject strongly disagreeing with prompt) to 100 (strongly agree).
Measured: Day 15 of treatment
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68) with 0 being none and high values being most.
Measured: Day 1 of treatment
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68) with 0 being none and high values being most.
Measured: Day 15 of treatment
Secondary outcomes (2)
Dietary intake
Dietary intake of subjects for 3-days prior to testing days analyzed using Food Processor Pro software for total calories, macro- and micro-nutrient composition
Measured: Day 1 of treatment
Dietary intake
Dietary intake of subjects for 3-days prior to testing days analyzed using Food Processor Pro software for total calories, macro- and micro-nutrient composition
Measured: Day 15 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start17 Mar 2021
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, randomized, control
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- ZyCal Bioceuticals
- Responsible party
- Principal investigator, Richard Bloomer, University of Memphis
- Investigators
- Richard Bloomer, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764110
- Sponsor's protocol ID
- PRO-FY2021-6
- Status last verified
- Aug 2022
- First submitted
- 18 Feb 2021
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Impact of Cyplexinol® on Inflammatory Status and Related Measures in Men and Women With Self-reported Joint Pain
- ClinicalTrials.gov ID
- NCT04764110
- Acronym / sponsor ID
- PRO-FY2021-6
- Conditions
- Joint Pain
- Keywords
- Cyplexinol, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- ZyCal Bioceuticals
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the impact of 900 mg Cyplexinol® taken daily on joint pain over a period of 15 days in comparison with a placebo will be determined using a cross-over double blind design with a 13 day wash out period. In addition, we will measure cytokine production and related variables during the two hour after subjects ingest a single dosage of Cyplexinol® or placebo on days 1 and 15.
Detailed description
Chronic inflammation can induce joint pain, which is a common problem among adult men and women. ZyCal Bioceuticals is a manufacturer of natural ingredients and finished nutritional supplements to support bone and joint health in humans. The core ingredient in all ZyCal products is Cyplexinol® (a Bone Morphogenetic Protein [BMP] Complex). BMP complexes have been shown to activate mesenchymal stem cells to help the body regenerate osteoblasts and chondrocytes. BMPs were initially identified in the 1970's as osteogenic factors which stimulate activation, proliferation, and differentiation of osteoprogenitor cells by binding BMP receptors and subsequent signaling through the SMAD pathway. BMPs have also been shown to reduce inflammation and promote healthy inflammatory signaling in joints and other tissues.
Cyplexinol® is delivered in the dietary supplement called Ostinol™, which has been safely used in oral form by thousands of people since 2007 for bone and joint health. Currently Cyplexinol® is considered a dietary supplement ingredient and has been awarded GRAS (generally recognized as safe).
Studies have been conducted to evaluate the safety and efficacy of Cyplexinol® as a dietary supplement for joint health (Garian, 2012; Scaffidi, 2017). Dosages of 150mg Cyplexinol® have been compared to a placebo (negative control) alone or in combination with glucosamine /chondroitin in randomized controlled trials for 4 -12 weeks. Endpoints examined have included joint stiffness, inflammation, pain, and overall quality of life. However, to date, no short-term studies have been conducted using Cyplexinol®, nor have any acute studies evaluated the impact of this agent on immune function.
In this study, the impact of 900 mg Cyplexinol® taken daily on joint pain over a period of 15 days in comparison with a placebo will be determined using a cross-over double blind design with a 13 day wash out period. In addition, we will measure cytokine production and related variables during the two hour post ingestion period after subjects ingest a single dosage of Cyplexinol® or placebo on days 1 and 15.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind, randomized, control
| Arm | Type | Receives |
|---|---|---|
| Cyplexinol | Experimental | Dietary Supplement: Cyplexinol900 mg daily (2 capsules) for 15 days |
| Placebo | Placebo comparator | Other: Placebo2 capsules daily for 15 days |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- body mass index (BMI) between 18-29.9 kg/m2 (not obese)
- no consumption of alcohol-containing beverages within 48 hours of testing
- experiencing self-reported joint pain with a minimum pain rating of 3/10 for at least the past 30 days
- engaged in structured exercise 2 or more days per week for the past 6 months or longer
- a negative verbal pre-study drug screen (alcohol abuse, amphetamines, benzodiazepines, cocaine, opioids, phencyclidine, barbiturates, cotinine), no history of use of illicit drugs or other substances of abuse within 12 months of the screening visit
Key exclusion criteria (5 listed)
- pregnant
- tobacco user
- active infection or illness of any kind
- rheumatic or osteoarthritic diagnosis
- Using anti-inflammatory medicines, pain medications, or dietary supplements (or not willing to cease for one-month prior to participation and throughout study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyplexinolpartially hydrolyzed Collagen and its associated proteins including Bone Morphogenetic Proteins (BMPs) | Dietary supplement | Cyplexinol |
| PlaceboMaltodextrin | Other | Placebo |
Primary outcome
TNF-alpha
Time frame: baseline of day 1
TNF-alpha measured in blood
TNF-alpha
Time frame: baseline of day 15
TNF-alpha measured in blood
TNF-alpha
Time frame: 60 min after treatment ingestion of day 1
TNF-alpha measured in blood
TNF-alpha
Time frame: 60 min after treatment ingestion of day 15
TNF-alpha measured in blood
TNF-alpha
Time frame: 120 min after treatment ingestion of day 1
TNF-alpha measured in blood
TNF-alpha
Time frame: 120 min after treatment ingestion of day 15
TNF-alpha measured in blood
IL-6
Time frame: baseline of day 1
IL-6 measured in blood
IL-6
Time frame: baseline of day 15
IL-6 measured in blood
IL-6
Time frame: 60 min after treatment ingestion of day 1
IL-6 measured in blood
IL-6
Time frame: 60 min after treatment ingestion of day 15
IL-6 measured in blood
IL-6
Time frame: 120 min after treatment ingestion of day 1
IL-6 measured in blood
IL-6
Time frame: 120 min after treatment ingestion of day 15
IL-6 measured in blood
IL-10
Time frame: baseline of day 1
IL-10 measured in blood
IL-10
Time frame: baseline of day 15
IL-10 measured in blood
IL-10
Time frame: 60 min after treatment ingestion of day 1
IL-10 measured in blood
IL-10
Time frame: 60 min after treatment ingestion of day 15
IL-10 measured in blood
IL-10
Time frame: 120 min after treatment ingestion of day 1
IL-10 measured in blood
IL-10
Time frame: 120 min after treatment ingestion of day 15
IL-10 measured in blood
IL-1beta
Time frame: baseline of day 1
IL-1beta measured in blood
IL-1beta
Time frame: baseline of day 15
IL-1beta measured in blood
IL-1beta
Time frame: 60 min after treatment ingestion of day 1
IL-1beta measured in blood
IL-1beta
Time frame: 60 min after treatment ingestion of day 15
IL-1beta measured in blood
IL-1beta
Time frame: 120 min after treatment ingestion of day 1
IL-1beta measured in blood
IL-1beta
Time frame: 120 min after treatment ingestion of day 15
IL-1beta measured in blood
osteocalcin
Time frame: baseline day 1
osteocalcin measured in blood
osteocalcin
Time frame: baseline day 15
osteocalcin measured in blood
osteocalcin
Time frame: 60 min after treatment ingestion of day 1
osteocalcin measured in blood
osteocalcin
Time frame: 60 min after treatment ingestion of day 15
osteocalcin measured in blood
osteocalcin
Time frame: 120 min after treatment ingestion of day 1
osteocalcin measured in blood
osteocalcin
Time frame: 120 min after treatment ingestion of day 15
osteocalcin measured in blood
alkaline phosphatase
Time frame: baseline day 1
alkaline phosphatase measured in blood
alkaline phosphatase
Time frame: baseline day 15
alkaline phosphatase measured in blood
alkaline phosphatase
Time frame: 60 min after treatment ingestion of day 1
alkaline phosphatase measured in blood
alkaline phosphatase
Time frame: 60 min after treatment ingestion of day 15
alkaline phosphatase measured in blood
alkaline phosphatase
Time frame: 120 min after treatment ingestion of day 1
alkaline phosphatase measured in blood
alkaline phosphatase
Time frame: 120 min after treatment ingestion of day 15
alkaline phosphatase measured in blood
Bone Morphogenetic Protein
Time frame: baseline day 1
Bone Morphogenetic Protein measured in blood
Bone Morphogenetic Protein
Time frame: baseline day 15
Bone Morphogenetic Protein measured in blood
Bone Morphogenetic Protein
Time frame: 60 min after treatment ingestion of day 1
Bone Morphogenetic Protein measured in blood
Bone Morphogenetic Protein
Time frame: 60 min after treatment ingestion of day 15
Bone Morphogenetic Protein measured in blood
Bone Morphogenetic Protein
Time frame: 120 min after treatment ingestion of day 1
Bone Morphogenetic Protein measured in blood
Bone Morphogenetic Protein
Time frame: 120 min after treatment ingestion of day 15
Bone Morphogenetic Protein measured in blood
Joint pain visual analog scale
Time frame: Day 1 of treatment
A 100mm visual analog scale will be used to assess joint pain. Scores range from 0 (subject strongly disagreeing with prompt) to 100 (strongly agree).
Joint pain visual analog scale
Time frame: Day 15 of treatment
A 100mm visual analog scale will be used to assess joint pain. Scores range from 0 (subject strongly disagreeing with prompt) to 100 (strongly agree).
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Day 1 of treatment
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68) with 0 being none and high values being most.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Day 15 of treatment
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68) with 0 being none and high values being most.
2 secondary outcomes
Dietary intake
Time frame: Day 1 of treatment
Dietary intake
Time frame: Day 15 of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Bloomer, PhD principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyplexinol in people with Joint Pain, run by University of Memphis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TNF-alpha (time frame: baseline of day 1). The study lists 46 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.